Clinical Research Associate, Sponsor Dedicated, Oncology

IQVIA; Durham (NC); On-site; USD 90,000 - 198,000; Full time

Job summary

IQVIA is seeking a Clinical Research Associate to ensure study sites run smoothly and in full compliance with GCP/ICH guidelines. You will conduct site visits, support patient recruitment, and train site staff to maintain high-quality data and regulatory documentation.

The role involves close collaboration with the study team, monitoring progress, and managing site finances. Oncology experience and strong communication skills are required to excel in this position.

Qualifications

• BS degree in a scientific discipline or healthcare preferred.
• Minimum 1 year of on-site monitoring experience in oncology; 2 years preferred.
• Strong knowledge of GCP and ICH guidelines, with oncology protocol expertise.
• Proficiency in Microsoft Office and excellent communication and organizational skills.
• Ability to manage time and financial aspects and build strong relationships with study sites.

Responsibilities

• Site Visits: Conduct selection, initiation, monitoring, and close-out visits per GCP/ICH.
• Recruitment Drive: Collaborate with sites to develop and track recruitment plans.
• Training & Communication: Provide protocol training and maintain regular site communication.
• Quality Assurance: Evaluate site practices for protocol adherence and raise quality issues.
• Study Progress: Track regulatory submissions, recruitment, enrollment, and data management.
• Documentation: Maintain TMF and ISF per regulatory requirements.
• Mentorship: Guide clinical staff through co-monitoring and training visits.
• Collaboration: Work closely with study team members to support execution.
• Financial Management: Manage site finances and retrieve invoices per local requirements.

Skills

Microsoft Office

Communication

Organization

Problem-solving

Education

BS Degree in a scientific discipline or healthcare

Job description

Role Overview

As a Clinical Research Associate, you'll be at the forefront of ensuring our study sites operate smoothly and efficiently. Your work will be pivotal in advancing groundbreaking research.

Key Responsibilities

• Site Visits: Conduct selection, initiation, monitoring, and close-out visits, ensuring compliance with Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.


• Recruitment Drive: Collaborate with sites to develop and track recruitment plans, ensuring project needs are met.


• Training & Communication: Provide protocol training and maintain regular communication with sites to manage expectations and address issues.


• Quality Assurance: Evaluate site practices for protocol adherence and elevate quality issues as needed.


• Study Progress: Track regulatory submissions, recruitment, enrollment, and data management to ensure smooth study progress.


• Documentation: Maintain essential documents in the Trial Master File (TMF) and Investigator’s Site File (ISF) as per regulatory requirements.


• Mentorship: Mentor clinical staff through co-monitoring and training visits.


• Collaboration: Work closely with study team members to support project execution.


• Financial Management: Manage site finances and retrieve invoices as per local requirements.

Qualifications

• Education: BS Degree in a scientific discipline or healthcare preferred.


• Experience: Minimum 1 year of on-site monitoring experience in oncology; 2 years preferred.


• Knowledge: Strong understanding of GCP and ICH guidelines, with expertise in oncology protocols.


• Skills: Proficiency in Microsoft Office, excellent communication skills, and strong organizational and problem-solving abilities.


• Attributes: Effective time and financial management, and the ability to build strong working relationships.

Why Join Us?

Be part of a team that’s driving innovation in clinical research. Your contributions will help shape the future of healthcare.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is $90,200.00 - $197,500.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.